Recall of some batches of NovoMix 30

Recall of some batches of NovoMix 30

The European Medicines Agency [EMA] has announced the recall of some batches of NovoMix 30 FlexPen and Penfill because of a manufacturing problem during the filling of the cartridges, which resulted in some batches of NovoMix 30 containing too high or too low amounts of insulin units per millilitre.

According to NovoNordisk, only a small percentage of cartridges (0.14%) contain a wrong amount. However, in the affected cartridges the level of insulin may vary between 50% and 150% of the labelled insulin units, which could lead to hypoglycaemia or hyperglycaemia.

The EMA recommends that patients using NovoMix 30 FlexPen/Penfill from the affected batches should be switched to products from unaffected batches or, if such batches are not available, to alternative treatment.